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Industry Best Practices Flashcards

7 cards from real RA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Industry Best Practices flashcards as text

  1. In the ALCOA+ data integrity framework, what does the added "C" stand for?

    Answer: Complete

    ALCOA+ adds Complete, Consistent, Enduring, and Available to the original Attributable, Legible, Contemporaneous, Original, Accurate.

  2. A research assistant notices an incorrect blood pressure value on a paper source document. What is the correct way to fix it?

    Answer: Draw a single line through the error, write the correction, and initial and date it

    GCP-compliant corrections keep the original entry legible and are attributable and dated.

  3. Who is ultimately responsible for signing the delegation of authority log that assigns study tasks to site staff?

    Answer: The principal investigator

    The PI delegates trial-related duties and stays responsible for supervising those individuals.

  4. Which step must be completed before any study-specific screening procedure is performed on a potential participant?

    Answer: Obtaining documented informed consent

    No protocol-specific procedure may be performed until informed consent is obtained and documented.

  5. The temperature log shows that the investigational product refrigerator went above its allowed range overnight. What should the research assistant do first?

    Answer: Quarantine the affected product and notify the sponsor before any further dispensing

    Product exposed to an excursion is quarantined until the sponsor decides whether it can still be used.

  6. According to ICH E6, what is the main purpose of essential documents?

    Answer: To allow evaluation of how the trial was conducted and of the quality of the data produced

    Essential documents show that the investigator, sponsor, and monitor complied with GCP and regulatory requirements.

  7. Under 21 CFR 312.62, how long must an investigator keep records for an IND drug study?

    Answer: 2 years after marketing approval, or 2 years after the investigation is discontinued and FDA is notified

    FDA requires retention for 2 years after approval for the indication, or 2 years after discontinuation and FDA notification.